Treatment of High Risk Adult Acute Lymphoblastic Leukemia (LAL-AR/2003)
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ClinicalTrials.gov Identifier: NCT00853008 |
Recruitment Status :
Completed
First Posted : February 27, 2009
Last Update Posted : April 7, 2020
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Condition or disease | Intervention/treatment | Phase |
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Acute Lymphoblastic Leukemia | Drug: Vincristine Drug: Daunorubicin Drug: Prednisone Drug: Mitoxantrone Drug: Cytosine Arabinoside Drug: Dexamethasone Drug: Methotrexate (MTX) Drug: Cytarabine Drug: ASP Drug: Mercaptopurine Drug: Teniposide Drug: Hydrocortisone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of High Risk Adult Acute Lymphoblastic Leukemia |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | December 2012 |

- Drug: Vincristine
Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)
- Drug: Daunorubicin
Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22
- Drug: Prednisone
Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28
- Drug: Mitoxantrone
Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation
- Drug: Cytosine Arabinoside
ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction
- Drug: Dexamethasone
Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)
- Drug: Methotrexate (MTX)
Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT
- Drug: Cytarabine
Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal
- Drug: ASP
ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)
- Drug: Mercaptopurine
Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation
- Drug: Teniposide
Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3
- Drug: Hydrocortisone
Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal
- To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients. [ Time Frame: 2 years ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- High risk ALL adult patients (age> 15 years)no treated previously
- High-risk ALL:
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One or more of the following:
- Age 30-60 yr.
- WBC count >25x109/L
- 11q23 or ALL1/AF4
- Very high-risk ALL:
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HR ALL and one or the following:
- Slow cytologic response (>10% blasts in BM on d14 of induction therapy).
- MRD>0.05% (by flow cytometry) at the end of consolidation
Exclusion Criteria:
- L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22).
- ALL Ph (BCR/ABL) positive.
- Bifenotipics ALL as EGIL criteria.
- Indifferentiated ALL.
- Patients with cardiac pathology
- Patients with chronic liver disease in activity fase
- Pulmonary disease
- Renal insufficiency not due to ALL
- Neurological disorders not due to ALL
- PS (grades 3 and 4) not due to ALL.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853008

Study Chair: | Ribera Josep Mª, Dr | PETHEMA Foundation |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00853008 |
Other Study ID Numbers: |
LAL-AR/2003 |
First Posted: | February 27, 2009 Key Record Dates |
Last Update Posted: | April 7, 2020 |
Last Verified: | April 2020 |
Acute Lymphoblastic Leukemia High-Risk (HR) Philadelphia Chromosome-Negative |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Dexamethasone Prednisone Hydrocortisone Methotrexate Vincristine |
Daunorubicin Mercaptopurine Mitoxantrone Teniposide Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |